Cleared Traditional

THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007

K882495 · Lakewood Biochemical Co., Inc. · Microbiology
Jul 1988
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K882495 is an FDA 510(k) clearance for the THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on July 1, 1988, 15 days after receiving the submission on June 16, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2300.

Submission Details

510(k) Number K882495 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1988
Decision Date July 01, 1988
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSG — Culture Media, Non-selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2300

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